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Clinical Trials/NCT01103219
NCT01103219TerminatedPhase 3

Nutrition, Growth and Development Among Very Preterm Infants

University of Oslo3 sites in 1 country50 target enrollmentStarted: August 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Terminated
Enrollment
50
Locations
3
Primary Endpoint
Reduction in discharge rate of small-for-gestational age very low birth weight infants
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The main purpose of this study is to evaluate the effect of increased supply of energy, protein, vitamin A and the long chain polyunsaturated fatty acids docosahexaenoic acid and arachidonic acid on growth, brain maturation and cognitive function.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Birth weight below 1,500 grams
  • •Written consent to participate from the parents

Exclusion Criteria

  • •Congenital malformations
  • •Clinical syndromes known to affect growth and development
  • •Critical illness and short life expectancy
  • •If participants refuse to participate

Outcomes

Primary Outcomes

Reduction in discharge rate of small-for-gestational age very low birth weight infants

Time Frame: 6 months corrected age

The primary endpoint is to reduce the discharge rate of very low birth weight infants that are small-for-gestational age, from 60 to 40%.

Secondary Outcomes

  • Evaluation of brain function and growth of infant(6 months corrected age)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Per Ole Iversen, MD

Professor

University of Oslo

Study Sites (3)

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